Quality Support (Internal Audit)

Company: Nesco Resource

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General Information
US-DE-Newark
$30.00 - $35.00 /Hour
4 Year Degree
Contractor
At least 5 year(s)
Not Specified
False
False
Job Description Job Description: Internal Audit Scheduling & Planning

This position is responsible for the site internal audit program.

Responsibilities include:
 
  • Gathering all the appropriate documentation required for internal audits.
  • Insure all appropriate elements of the QSIT are addressed.
  • Insure all internal SOPs, WIs, Templates, Forms, Records, are assessed.
  • Review ISO 13485 elements and other regulatory requirements are incorporated.
  • Track audits against schedule and contact appropriate parties as needed.
  • Internal Audit Checklist Creation
  • Create standardized IA checklists for each department and element audited.
  • Ensure previous audit findings are incorporated into the checklists
  • Highlight ALL internal requirements and make sure they are part of the document
  • Highlight ALL external requirements (i.e.13485) for inclusion into the document.
  • Internal Audit Report Reviewing & Writing
  • Write final reports for audits that are completed
  • Review Reports which are created by other internal auditors for completeness
  • Provide feedback to other auditors so audit reports are consistent and uniform
  • All IA Reports and Findings will be reviewed with the Sr. Quality Director.
  • Conducting Internal Audits
  • Gather appropriate document and create the required checklists.
  • Contract appropriate individuals and schedule meetings
  • Perform audits that are detailed in the internal audit schedule
  • Write IA Reports detailing findings and recommendations
  • Create any required CAPAs for corrective and preventative actions.
  • Tactical Management of Internal Audit Program
  • Engage and provide guidance to other auditors who are participating in the program.
  • Ensure audits are preformed on time and the required resources are available.
  • Escalate any issues to the Sr. Quality Director.
  • CAPA Creation and Involvement
  • Scale audit findings and rate accordingly as Major/Minor or Recommendations.
  • Create CAPAs for significant findings based on Regulatory or Product Risk.
  • Review CAPAs which are created by other internal auditors for consistency.
  • Create Preventative Actions as part of the Recommendations which are documented.
  • Internal Audit Metrics
  • Measure Program against plan and modify schedule accordingly.
  • Categorize Audit Findings to aid in determine quality system/element weaknesses.
  • Assist in reporting CAPAs related to Internal Audits.
    • Job Requirements 
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